|- candidate number||15791|
|- NTR Number||NTR4297|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-nov-2013|
|- Secondary IDs|| |
|- Public Title||Efficacy of the self-help intervention "This is your life"|
|- Scientific Title||Efficacy of the self-help intervention "This is your life": A randomized controlled trial to improve well-being and flourishing for adults with a low or moderate level of well-being|
|- hypothesis||1. Does participating in the self-help intervention "This is your life", with or without emailcounseling leads to a significant higher level of emotional, psychological and social well-being compared to a waiting-list control group?|
2. Are the effects of the self-help intervention "This is your life" maintained at 6 and 12 months follow-up?
3. Are the effects of the self-help intervention "This is your life" with or without emailcounseling mediated by the theoretically effective components (positive emotions, use of strengts, optimism, self compassion, resilience, and positive relations)?
4. Does participating in the self-help intervention "This is your life" with or without emailcounseling leads to significant more flourishers?
5. Which groups of participants benefit from the self-help intervention "This is your life", and which groups not or less? (for example men/women, high/low education, languishers/moderately mentally healthy participants)
|- Healt Condition(s) or Problem(s) studied||Wellbeing, Resilience, Positive mental health|
|- Inclusion criteria||• Participant is between 18 and 65 years|
• Participant experiences a low or moderate level of well-being ("languishers" or "moderately mentally healthy")
• Participant has sufficient internet connection and an e-mailadress
• Participant is willing to invest an average time of 4 hours per week during 8-12 weeks when he or she is in one of
the experimental conditions.
• Participant masters the Dutch language to fill in questionnaires and follow the self-help intervention
• Participant gives informed consent for participating in the study.
|- Exclusion criteria||Participants who are flourishing and thus have high levels of well-being: They score 1) high (4 or 5) on one or
more items of the subscale "emotional well-being" of the Mental Health Continuum Short Form (MHC-SF), and 2)
high (4 or 5) on six or more items of a combination of the subschales "social well-being" and "psychological wellbeing"
of the MHC-SF.|
• Presence of serious depressive or anxiety symptoms: score of >10 on the depressionscale and/or score of >10
on the anxietyscale of the Hospital Anxiety and Depression Scale (HADS).
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2014|
|- planned closingdate||1-jul-2015|
|- Target number of participants||372|
|- Interventions||Study design:|
A randomized controlled trial with three conditions:
1. Experimental condition 1: the self-help intervention "This is your life, experience the effects of positive psychology" with
weekly proces and content e-mail counseling.
2. Experimental condition 2: the self-help intervention "This is your life, experience the effects of positive psychology"
without e-mail counseling, but with a weekly e-mail containing frequently asked questions and answers (FAQ).
3. Control condition: a waiting list control group, participants receive the self-help intervention after six months.
Participants in the experimental conditions have 12 weeks to independently follow the self-help intervention consisting
eight lessons. Topics that will be covered are: the importance of positive emotions, discovering and using strengths,
optimism and hope, being friendly to yourself, coping with adversity, developing positive relationships, and
connectedness and giving. The intervention gives information and practical exercises which the participant can practice
independently. The group with e-mail counseling will also have weekly contact with their counselor about their progress
and possible problems. The control condition consists of participants who are on a waiting list and they will receive the
self-help intervention after six months.
|- Primary outcome||The primary outcome is the level of well-being, measured with the MHC-SF.|
|- Secondary outcome||Secundary study parameters/outcome of the study (if applicable):|
Secondary outcomes are flourishing, mental illnesses (depression and anxiety), positive and negative emotions,
resilience, use of strengths, optimism, self-compassion, positive relationships, health care use and productivity losses.
Demographics, personality characteristics and positive and negative life events during the last 12 months will also be
|- Timepoints||Questionnaires are taken online before (T0) and after (T1) the intervention, six months after the intervention (T2) and 12
months after the intervention (T3).|
|- Trial web site||www.veerkrachtenwelbevinden.nl|
|- CONTACT FOR PUBLIC QUERIES||Msc. Marijke Schotanus-Dijkstra|
|- CONTACT for SCIENTIFIC QUERIES||Msc. Marijke Schotanus-Dijkstra|
|- Sponsor/Initiator ||University of Twente|
(Source(s) of Monetary or Material Support)
|- Brief summary||Prevention and reduction of mental illnesses are central in mental health care. Until now, the emphasis was on prevention
and treatment of mental disorders, but recently it is argued that it is highly relevent to invest in well-being as this will
probably contribute to the prevention of mental disorders. Individuals who score high on emotional, psychological and
social well-being are also known as "flourishers". Promoting flourishing is a new field in positive psychology. Individual
interventions are mostly designed to strengthen individual competencies that improve emotional, psychological and social
well-being. Examples of these competencies are strengtening positive emotions, examining values, intrinsic needs and
strengths, optimistic goal striving, maintaining positive relationships and coping with adversity (resilience). A recent meta-analysis shows that there is a diversity of positive psychology interventions with small but significant effect sizes for wellbeing.
However, these interventions are mostly minimalistic, therefore, more durable effects are not yet expected from
these interventions. It is concluded that a more intensive, comprehensive positive psychology intervention is needed to
promote well-being and flourishing in the population. The University of Twente has now developed a self-help intervention
for adults with a low or moderate level of well-being: "This is your life, experience the effects of positive psychology".
The aim is to study the effectiveness on well-being of the self-help intervention "This is your life, experience the effects of
positive psychology" in a randomized controlled trial. We expect that the intervention, with or without e-mail counseling, is
superior to a waiting list control group.
|- Main changes (audit trail)|
|- RECORD||29-nov-2013 - 3-jan-2014|